Evaluation of the patient hypertension guidelines and self-management tools
| ISRCTN | ISRCTN28843954 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28843954 |
| Protocol serial number | 06-482 |
| Sponsor | McMaster University (Canada) |
| Funder | Canadian Hypertension Education Program (CHEP) (Canada) |
- Submission date
- 15/03/2007
- Registration date
- 09/05/2007
- Last edited
- 16/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Janusz Kaczorowski
Scientific
Scientific
Primary Care & Community Research at the Child & Family Research Institute
Suite 320, 5950 University Boulevard
Department of Family Practice
University of British Columbia
Vancouver
V6T 1Z3
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | A patient information leaflet/booklet (based on the Canadian Hypertension Education Program [CHEP] Public Recommendations) and self-management tools (e.g. blood pressure 'tracker', medication diary, and lifestyle changes record) can impact on blood pressure related knowledge, attitudes, and behaviours among patients with elevated blood pressure in family practice. |
| Ethics approval(s) | Final approval received from the Hamilton Health Sciences/McMaster University Faculty of Health Sciences Research Ethics Board on the 23rd January 2007 (ref: 04-682). |
| Health condition(s) or problem(s) studied | Elevated blood pressure/hypertension |
| Intervention | This is a single-blind randomised controlled trial of a CHEP-based leaflet/booklet and interactive patient self-management tools, including a blood pressure tracker, for patients with hypertension compared with the usual family practice management and provision of the 2007 CHEP Public Recommendations. Distribution of a patient information leaflet/booklet (based on the Canadian Hypertension Education Program (CHEP) Public Recommendations) and self-management tools (e.g. blood pressure 'tracker', medication diary, and lifestyle changes record). Patients allocated to the control group will receive treatment as usual from their physician, with the addition of a copy of the Canadian Hypertension Education Program (CHEP) 2007 Public Recommendations. |
| Intervention type | Other |
| Primary outcome measure(s) |
Change in blood pressure related knowledge, attitudes, and behaviours among patients with elevated blood pressure in family practice. |
| Key secondary outcome measure(s) |
Blood pressure will be measured in the family physicians office at baseline and exit visits. |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Adult patients with elevated Blood Pressure (BP) (Systolic Blood Pressure [SBP] greater than 140 mmHg or greater than 130 mmHg if diabetic) who own or intend to purchase a home BP monitoring device 2. Patients will be either undergoing monitoring for a possible diagnosis of hypertension, or be uncontrolled hypertensives |
| Key exclusion criteria | Patients who do not own or intend to purchase a home BP monitoring device will be excluded |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
Primary Care & Community Research at the Child & Family Research Institute
Vancouver
V6T 1Z3
Canada
V6T 1Z3
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2010 | Yes | No |